Risk of virilization in children and women following secondary exposure to testosterone in topically administered testosterone gel. Advise children and women to avoid contact with application sites of men using testosterone gel. (See Virilization in Children and Women from Secondary Exposure to Testosterone under Cautions.)

Advise men using testosterone gel to strictly adhere to recommended instructions for use. (See Administration under Dosage and Administration.)

REMS:

FDA approved a REMS for testosterone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of testosterone and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

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What is this medicine?

TESTOSTERONE (tes TOS ter one) is the main male hormone. It supports normal male traits such as muscle growth, facial hair, and deep voice. This medicine is used in males to treat low testosterone levels.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

breast cancer

diabetes

heart disease

kidney disease

liver disease

lung disease

prostate cancer, enlargement

an unusual or allergic reaction to testosterone, soy proteins, other medicines, foods, dyes, or preservatives

this drug is not for use in females

How should I use this medicine?

Patients should read and understand how to use medicine. Follow the directions given to you by your doctor or health care professional. This medicine is placed on the gums in the mouth. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

medicines for diabetes

medicines that treat or prevent blood clots like warfarin

oxyphenbutazone

propranolol

steroid medicines like prednisone or cortisone

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. They will need to check the level of testosterone in your blood.

Check that this medicine is still in place after you brush your teeth, use mouthwash, eat, or drink.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

This drug is banned from use in athletes by most athletic organizations.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

breast enlargement

breathing problems

changes in mood, especially anger, depression, or rage

dark urine

general ill feeling or flu-like symptoms

gum blister

light-colored stools

loss of appetite, nausea

nausea, vomiting

right upper belly pain

stomach pain

swelling of ankles

too frequent or persistent erections

trouble passing urine or change in the amount of urine

unusually weak or tired

yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

acne

altered, bitter taste

change in sex drive or performance

dry mouth

gum irritation, pain, swelling

headache

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not use medicine from a damaged blister package. Throw away any unused medicine after the expiration date.

Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.

Last Updated: December 10, 2009

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